1. Field of the Invention
The present invention relates to an ostomy carrier device adapted for use in a collecting system for use by patients having a stoma. More specifically the present invention relates to an ostomy carrier device comprising a flexible adhesive base plate with an opening for securing the carrier device to a patient's, or user's, skin around a stoma, as well as a circumferential mounting flange made of a flexible material and being adapted for removable and adhesive connection with a coupling element of an ostomy collecting bag, the carrier device and the collecting bag making up a collecting system.
2. Description of the Related Art
In collecting systems in general, the base plate of the carrier device must be able to remain on the user over a long period of time, for example up to 8–10 days. During this whole period of time, the carrier device must be capable of withstanding deformation due to the user's movements, washing, exposure to bag replacements, etc. Conventionally, the base plate of such a carrier device is designed as a thin adhesive wafer or pad, to which is attached a coupling means for coupling the carrier device to a collecting bag. In the collecting systems which until now have been dominant on the market, the coupling has been provided by first and second relatively rigid coupling rings on the base plate and collecting bag, respectively, the coupling rings being detachably connectable to each other. When such a rigid ring system is attached to the base, movements and deformations to the base plate will not influence the locking engagement between the coupling rings, this resulting in a long-lasting connection between the collecting bag and the base plate.
However, the above conventional system has a number of drawbacks. For example, the rigid coupling rings may be uncomfortable for the user during use as they prevent the base plate from following the contours of the body when the user moves, and it does not provide the desired shock absorbing effect between the collecting bag and the user, which, of course, reduces comfort. Further, such a coupling ring system is relatively bulky and thus difficult to hide behind many types of garment, this presenting a cosmetic and aesthetic problem to many users and thus a reduced acceptance.
In the past proposals have been suggested for novel and improved coupling systems overcoming the above problems. One such system relies on a coupling comprising a circumferential flange firmly attached to the base plate and made of a flexible material being adapted for removable and adhesive connection with a coupling element of a ostomy collecting bag. Another similar system comprises a circumferential flange attached to the base plate corresponding to the inner edge portion of the flange, the outer portion of the flange being free to move relative to the base plate.
The carrier devices of the above-described systems have proven very comfortable to wear; however, due to a number of problems such systems have until now not been successful.
One problem with these systems arises when the flexible flange is forced to follow the movements of the base plate, this resulting in a tendency for the collecting bag to detach from the flange. It is believed that this is due to stretching of the flange material resulting in reduced adhering properties of the flange surface, especially when the material of one of the flanges is non-adhesive, the adhesive being on either the coupling element of the collecting bag or the base plate flange. Eventually a leak will be formed which, indeed, is unacceptable to the user.
One attempt to overcome these problems is described in EP 0 276 042 disclosing a base plate with a relatively rigid flange attached, the adhesive connection taught between bag and carrier device being provided by a number of layers of adhesive applied to the flange of the base plate and activated one after the other, which limits the number of times the bag can be changed to the number of layers of adhesive. Use of such rigid flange member may serve to protect the bond between the flange member and the collecting bag; however, it reintroduces the rigidity of the above described coupling ring system. Furthermore, a new problem is introduced as the rigid flange member allows the coupling element on the ostomy bag to peel off as the collecting bag moves relative to the carrier device during normal use of the system.
A different approach to negotiate the above problems is described in WO 96/38106 in which a soft flexible ring of a foam material is mounted on the base plate, this allowing the base plate flange and the flexible connecting flange of a collecting bag mounted thereon to move relative to the base plate. This approach reduces the tendency of the adhesive bond between the carrier device and the collecting bag to break up, however, after removal of the used collecting bag, the deformations to the foam ring thereby introduced will leave an uneven or wrinkled surface for the next collecting bag to be mounted, thereby jeopardising the sealing action.